MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIP; PEN NEEDLE

Model Number	AN 3540KRO
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle broke off in abdomen.Patient went to urgent care and they sent him to the er with instructions to get a sonogram.The er did not do a sonogram but they did an x-ray and said they didn't ss the needle.Patient says he can feel the needle in his abdomen and is worried it is going to get infected or cause other pain and damage to his stomach area.Customer service instructed patient to follow the advice of his physician.

• Brand Name: UNIFINE PENTIP
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer (Section G): OWEN MUMFORD LIMITED; brook hill; woodstock, ozfordshire OX20 1TU; UK OX20 1TU
• Manufacturer Contact: jeanetta mckinley ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 20191471
• Report Number: 8021764-2024-00008
• Device Sequence Number: 20867542
• Product Code: FMI
• UDI-Device Identifier: 00041260007781
• UDI-Public: 00041260007781
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AN 3540KRO
• Device Lot Number: 23A9004.D259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG